Cleared Traditional

K890032 - IMX TOXO IGM ANTIBODY ASSAY

K890032 is an FDA 510(k) clearance for IMX TOXO IGM ANTIBODY ASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K890032 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
170d
Days
Class 2
Risk

K890032 is an FDA 510(k) clearance for the IMX TOXO IGM ANTIBODY ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 170 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K890032

510(k) Number K890032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1989
Decision Date June 23, 1989
Days to Decision 170 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 102d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGD Device Classification - Class 2, Special Controls

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 83
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K890032.
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST
K893200 · Gull Laboratories, Inc. · Dec 1989
TOXO ELISA TEST SYSTEM
K891781 · Zeus Scientific, Inc. · Jul 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · Abbott Laboratories · Jun 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
K883937 · Ortho Diagnostic Systems, Inc. · Feb 1989
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · Ortho Diagnostic Systems, Inc. · Oct 1988
BIOTROL TOXO ELISA TEST M
K873293 · Biotrol, USA, Inc. · Apr 1988